FDA Expands Use Of HPV Vaccine Gardasil For Vaginal, Vulvar Cancer Prevention

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Regulatory Affairs / Drug Approvals;  Cancer / Oncology;  Women's Health / Gynecology
Article Date: 16 Sep 2008 - 5:00 PDT

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FDA on Friday approved expanding the use of Merck's human papillomavirus vaccine Gardasil to protect against cancers of the vagina and vulva, the AP/MSNBC.com reports (AP/MSNBC.com, 9/12). According to an FDA release, Gardasil first was approved by FDA in 2006 for girls and women ages nine to 26 to prevent cervical cancer cases caused by HPV strains 16 and 18, genital warts cases caused by HPV strains 6 and 11, and precancerous genital lesions caused by HPV strains 6, 11, 16 and 18. FDA in June denied Merck's request to approve the vaccine for women ages 27 to 45.

Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research, said that there now is "strong evidence" that Gardasil "can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer." Although vaginal and vulvar cancers are "rare," the "opportunity to help prevent them is potentially an important additional benefit from immunization against HPV," Goodman said (FDA release, 9/12).

According to the AP/MSNBC.com, Merck followed about 15,000 women over a two-year period as part of a clinical study for the vaccine. One group of participants was given the vaccine and the other was not. Ten women in the group that did not receive the vaccine developed precancerous vulvar lesions and nine developed similar vaginal lesions because of HPV infection. No women in the Gardasil group developed such lesions (AP/MSNBC.com, 9/12).

Rick Haupt, head of Merck's clinical research program for Gardasil, said that the clinical trials found the vaccine to be 100% effective in preventing the two cancers and that additional follow-up to the trials has given researchers "more rigorous data" (Reuters, 9/12). Haupt also said that the availability of Gardasil as prevention for the two additional cancers is "fabulous stuff," adding that Merck is studying the effectiveness of the vaccine in men with the aim of submitting data to FDA by the end of the year (Favole, Dow Jones/Morning Star, 9/12).

FDA noted that Gardasil does not protect against HPV infections that women might already have at the time of vaccination and encouraged women to get regular Pap tests even after they have been vaccinated (FDA release, 9/12).

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